drugset / Trial / NCT02577718

Safety and Effectiveness of Novel Nitroglycerin Based Catheter Lock Solution

NCT02577718

NaSingle-groupOpen-labelPrevention

Summary

The objective of this Phase I/II pilot study is to evaluate the safety and effectiveness of a non- antibiotic chelator based lock solution that contains nitroglycerin in combination with sodium citrate and ethanol (NiCE lock solution) for prevention of central line associated bloodstream infection (CLABSI). * The primary objective of this study is to evaluate the safety and estimate the rate of adverse events associated with the NiCE lock solution. * The second primary objective is to estimate the rate of CLABSI in patients receiving the NiCE lock solution.

Timeline

Start
2015-11
Primary completion
2016-06-22
Completion
2016-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Nitroglycerin Unknown 15 ug/ml Other
Subject Nitroglycerin Unknown 30 ug/ml Other
Background Alcohol Other / unclassified 22 % Other
Background sodium citrate Unknown 4 % Other